[Federal Register Volume 62, Number 154 (Monday, August 11, 1997)]
[Rules and Regulations]
[Pages 42921-42928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21144]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300521; FRL-5732-7]
RIN 2070-AB78
Glyphosate; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of glyphosate, per se in or on dry peas, pea vines, hay, and
silage, lentils, and kidney (cattle, goats, horses and sheep). This
action is in response to EPA's granting of emergency exemptions under
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act
authorizing use of the pesticide on dry peas, lentils and chickpeas.
This regulation establishes a maximum permissible level for residues of
glyphosate in this food commodity pursuant to section 408(l)(6) of the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996. The tolerance will expire and is revoked on
August 30, 1998.
DATES: This regulation is effective August 11, 1997. Objections and
requests for hearings must be received by EPA on or before October 10,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300521], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300521], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300521]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Virginia Dietrich,
Registration Division 7505C, Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9359, e-mail:
dietrich.virginia@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for
residues of the herbicide N-(Phosphonomethyl)glycine, in or on dry
peas, pea vines, hay, and silage, lentils, and kidney (cattle, goats,
horses and sheep) at 5, 60, 200, 90, 5, and 4, respectively part per
million (ppm). These tolerances will expire and are revoked on August
30, 1998. After August 30, 1998, EPA will publish a document in the
Federal Register to remove the revoked tolerance from the Code of
Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq . The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and
[[Page 42922]]
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue***.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerance to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Glyphosate on (Dry Peas, Lentils, and
Garbanzo Beans) and FFDCA Tolerances
The Agency determined that an urgent, non-routine situation exists
in areas where dense populations of Canada thistle develop in dry pea,
chickpea and lentil crops in Idaho, Oregon and Washington. Crop loss of
up to 100% may occur in areas heavily infested with Canada thistle.
Both pre- and post-emergence herbicides are registered for these crops,
but they are ineffective in controlling Canada thistle. Spot treatment
with glyphosate to eliminate Canada thistle will not improve dry pea,
chick pea and lentil crop yields this year since the application will
also destroy the surrounding crop. However, the use of glyphosate will
eliminate the Canada thistle pest and future crops are expected to
improve. After having reviewed the submission, EPA concurs that
emergency conditions exist for this state. EPA has authorized under
FIFRA section 18 the use of glyphosate on dry peas, garbanzo beans and
lentils) for control of Canada thistle.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of glyphosate in or on dry
peas, garbanzo beans and lentils. In doing so, EPA considered the new
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerance under FFDCA section 408(l)(6) would be consistent
with the new safety standard and with FIFRA section 18. Consistent with
the need to move quickly on the emergency exemption in order to address
an urgent non-routine situation and to ensure that the resulting food
is safe and lawful, EPA is issuing this tolerance without notice and
opportunity for public comment under section 408(e), as provided in
section 408(l)(6). Although these tolerances will expire and are
revoked on August 30, 1998, under FFDCA section 408(l)(5), residues of
the pesticide not in excess of the amounts specified in the tolerance
remaining in or on dry peas, garbanzo beans, and lentils after that
date will not be unlawful, provided the pesticide is applied in a
manner that was lawful under FIFRA. EPA will take action to revoke this
tolerance earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because this tolerance is being approved under emergency conditions
EPA has not made any decisions about whether glyphosate meets EPA's
registration requirements for use on dry peas, garbanzo beans, and
lentils or whether a permanent tolerance for this use would be
appropriate. Under these circumstances, EPA does not believe that this
tolerance serves as a basis for registration of glyphosate by a State
for special local needs under FIFRA section 24(c). Nor does this
tolerance serve as the basis for any State other than Idaho, Oregon,
and Washington to use this pesticide on this crop under section 18 of
FIFRA without following all provisions of section 18 as identified in
40 CFR part 166. For additional information regarding the emergency
exemption for glyphosate, contact the Agency's Registration Division at
the address provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses
[[Page 42923]]
the RfD to evaluate the chronic risks posed by pesticide exposure. For
shorter term risks, EPA calculates a margin of exposure (MOE) by
dividing the estimated human exposure into the NOEL from the
appropriate animal study. Commonly, EPA finds MOEs lower than 100 to be
unacceptable. This hundredfold MOE is based on the same rationale as
the hundredfold uncertainty factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute'', ``short-term'',
``intermediate term'', and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 3
sources are not typically added because of the very low probability of
this occurring in most cases, and because the other conservative
assumptions built into the assessment assure adequate protection of
public health. However, for cases in which high-end exposure can
reasonably be expected from multiple sources (e.g. frequent and
widespread homeowner use in a specific geographical area), multiple
high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (non-nursing
infants less than 1 year old ) was not regionally based.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action, EPA has sufficient data to assess the hazards of
glyphosate and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
residues of glyphosate on dry peas, pea vines, hay, and silage,
lentils, and kidney (cattle, goats, horses and sheep) at 5, 60, 200,
90, 5, and 4 ppm, respectively. EPA's assessment of the dietary
exposures and risks associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable
[[Page 42924]]
subgroups of consumers, including infants and children. The nature of
the toxic effects caused by glyphosate are discussed below.
1. Acute toxicity. No endpoint of concern was identified by the
Office of Pesticide Programs .
2. Short - and intermediate - term toxicity. No effects were
observed in a 21-day dermal toxicity study at the limit dose. No
adverse effects were observed in the developmental toxicity study in
rats up to 1,000 mg/kg/day and in rabbits at up to 175 mg/kg/day.
3. Chronic toxicity. EPA has established the RfD for glyphosate at
2 milligrams/kilogram/day (mg/kg/day). This RfD is based on the
maternal toxicity NOEL of 175 mg/kg/day from a rabbit developmental
toxicity study using an uncertainty factor (UF) of 100. The lowest
observed effect level (LOEL) of 350 mg/kg/day (highest dose tested) was
based on treatment-related findings of diarrhea, nasal discharge, and
death (62.5% of does died by gestation day 21). Developmental toxicity
was not observed at any dose tested.
4. Carcinogenicity. Glyphosate has been classified as a Group E
chemical (evidence of non-carcinogenicity for humans) by the Office of
Pesticide Programs. The classification was based on a lack of
convincing evidence of carcinogenicity in adequate studies with two
animal species, rat and mouse.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.364, 185.3500, 186.3500) for the combined residues of
glyphosate and its metabolite aminomethylphosphonic acid in or on
certain raw agricultural commodities ranging from 0.1 ppm in peanuts to
200 ppm in alfalfa. This regulation also establishes a tolerance for
secondary residues in kidney (cattle, goats, horses, and sheep). Risk
assessments were conducted by EPA to assess dietary exposures and risks
from glyphosate as follows:
i. Acute exposure and risk. No endpoint was identified for this
duration of exposure, therefore no assessment was necessary. Acute
dietary risk assessments are performed for a food-use pesticide only if
a toxicological study has indicated the possibility of an effect of
concern occurring as a result of a 1 day or single exposure.
ii. Chronic exposure and risk. In conducting this exposure
assessment, EPA has made very conservative assumptions--that 100% of
dry peas, lentils, and chickpeas and all other commodities having
glyphosate tolerances would contain glyphosate residues and that those
residues would be at the level of the respective tolerances--which
result in an overestimate of human dietary exposure. Thus, in making a
safety determination for this tolerance, EPA is taking into account
this conservative exposure assessment.
All the glyphosate tolerances (published, pending, and including
these Section 18 tolerances) result in a Theoretical Maximum Residue
Contribution (TMRC) that is equivalent to the following percentages of
the RfD:
------------------------------------------------------------------------
Subgroups Percentage of RFD
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U.S Population............................ 1.2
Nursing Infants........................... 1.2
Non-Nursing Infants (<1 year="" old).........="" 3.3="" children="" (1-6="" years="" old)..................="" 2.6="" children="" (7-12="" years="" old).................="" 1.8="" western="" region............................="" 1.3="" ------------------------------------------------------------------------="" the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (48="" states);="" (2)="" those="" for="" infants="" and="" children;="" and,="" (3)="" the="" other="" subgroups="" for="" which="" the="" percentage="" of="" the="" rfd="" occupied="" is="" greater="" than="" that="" occupied="" by="" the="" subgroup="" u.s.="" population="" (48="" states).="" iii.="" cancer="" risk.="" glyphosate="" has="" been="" classified="" as="" a="" group="" e="" chemical="" (evidence="" of="" non-carcinogenicity="" for="" humans)="" by="" the="" office="" of="" pesticide="" programs="" cancer="" peer="" review="" committee.="" 2.="" from="" drinking="" water.="" based="" on="" information="" in="" the="" epa's="" files,="" glyphosate="" is="" not="" persistent="" and="" not="" mobile.="" a="" maximum="" contaminant="" level="" has="" been="" established="" by="" the="" agency's="" office="" of="" water="" (ow)="" for="" residues="" of="" glyphosate="" in="" drinking="" water="" at="" 0.7="" ppm.="" ow="" has="" also="" established="" health="" advisory="" levels="" for="" glyphosate="" in="" drinking="" water="" at="" the="" following="" levels:="" child,="" 10="" kg="" of="" body="" weight...............="" 1-day...................................="" 20="" mg/l="" 10-day..................................="" 20="" mg/l="" longer-term.............................="" 1="" mg/l="" adult,="" 70="" kg="" of="" body="" weight...............="" lifetime................................="" 0.7="" mg/l="" i.="" acute="" exposure="" and="" risk.="" no="" endpoint="" of="" concern="" was="" identified="" by="" the="" agency="" so="" this="" risk="" assessment="" was="" not="" required.="" ii.="" chronic="" exposure="" and="" risk.="" because="" the="" agency="" lacks="" sufficient="" water-related="" exposure="" data="" to="" complete="" a="" comprehensive="" drinking="" water="" risk="" assessment="" for="" many="" pesticides,="" epa="" has="" commenced="" and="" nearly="" completed="" a="" process="" to="" identify="" a="" reasonable="" yet="" conservative="" bounding="" figure="" for="" the="" potential="" contribution="" of="" water-related="" exposure="" to="" the="" aggregate="" risk="" posed="" by="" a="" pesticide.="" in="" developing="" the="" bounding="" figure,="" epa="" estimated="" residue="" levels="" in="" water="" for="" a="" number="" of="" specific="" pesticides="" using="" various="" data="" sources.="" the="" agency="" then="" applied="" the="" estimated="" residue="" levels,="" in="" conjunction="" with="" appropriate="" toxicological="" endpoints="" (rfd's="" or="" acute="" dietary="" noel's)="" and="" assumptions="" about="" body="" weight="" and="" consumption,="" to="" calculate,="" for="" each="" pesticide,="" the="" increment="" of="" aggregate="" risk="" contributed="" by="" consumption="" of="" contaminated="" water.="" while="" epa="" has="" not="" yet="" pinpointed="" the="" appropriate="" bounding="" figure="" for="" exposure="" from="" contaminated="" water,="" the="" ranges="" the="" agency="" is="" continuing="" to="" examine="" are="" all="" below="" the="" level="" that="" would="" cause="" glyphosate="" to="" exceed="" the="" rfd="" if="" the="" tolerance="" being="" considered="" in="" this="" document="" were="" granted.="" the="" agency="" has="" therefore="" concluded="" that="" the="" potential="" exposures="" associated="" with="" glyphosate="" in="" water,="" even="" at="" the="" higher="" levels="" the="" agency="" is="" considering="" as="" a="" conservative="" upper="" bound,="" would="" not="" prevent="" the="" agency="" from="" determining="" that="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" if="" the="" tolerance="" is="" granted.="" 3.="" from="" non-dietary="" exposure.="" glyphosate="" is="" registered="" for="" uses="" on="" outdoor="" non-food="" sites="" such="" as="" turf="" and="" ornamentals.="" these="" uses="" may="" result="" in="" non-occupational="" exposures.="" however,="" since="" no="" toxicological="" endpoints="" for="" non-dietary="" exposures="" have="" been="" identified,="" the="" resulting="" risks="" cannot="" be="" assessed,="" therefore="" these="" exposures="" have="" not="" been="" estimated.="" 4.="" cumulative="" exposure="" to="" substances="" with="" common="" mechanism="" of="" toxicity.="" section="" 408(b)(2)(d)(v)="" requires="" that,="" when="" considering="" whether="" to="" establish,="" modify,="" or="" revoke="" a="" tolerance,="" the="" agency="" consider="" ``available="" information''="" concerning="" the="" cumulative="" effects="" of="" a="" particular="" pesticide's="" residues="" and="" ``other="" substances="" that="" have="" a="" common="" mechanism="" of="" toxicity.''="" the="" agency="" believes="" that="" ``available="" information''="" in="" this="" context="" might="" include="" not="" only="" toxicity,="" chemistry,="" and="" exposure="" data,="" but="" also="" scientific="" policies="" and="" methodologies="" for="" understanding="" common="" mechanisms="" of="" toxicity="" and="" conducting="" cumulative="" risk="" assessments.="" for="" most="" pesticides,="" although="" the="" agency="" has="" some="" information="" in="" its="" files="" that="" may="" turn="" out="" to="" be="" helpful="" in="" eventually="" determining="" whether="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" toxicity="" with="" any="" other="" substances,="" epa="" does="" not="" at="" this="" time="" have="" the="" methodologies="" to="" resolve="" the="" complex="" scientific="" issues="" concerning="" common="" mechanism="" of="" toxicity="" in="" a="" [[page="" 42925]]="" meaningful="" way.="" epa="" has="" begun="" a="" pilot="" process="" to="" study="" this="" issue="" further="" through="" the="" examination="" of="" particular="" classes="" of="" pesticides.="" the="" agency="" hopes="" that="" the="" results="" of="" this="" pilot="" process="" will="" increase="" the="" agency's="" scientific="" understanding="" of="" this="" question="" such="" that="" epa="" will="" be="" able="" to="" develop="" and="" apply="" scientific="" principles="" for="" better="" determining="" which="" chemicals="" have="" a="" common="" mechanism="" of="" toxicity="" and="" evaluating="" the="" cumulative="" effects="" of="" such="" chemicals.="" the="" agency="" anticipates,="" however,="" that="" even="" as="" its="" understanding="" of="" the="" science="" of="" common="" mechanisms="" increases,="" decisions="" on="" specific="" classes="" of="" chemicals="" will="" be="" heavily="" dependent="" on="" chemical="" specific="" data,="" much="" of="" which="" may="" not="" be="" presently="" available.="" although="" at="" present="" the="" agency="" does="" not="" know="" how="" to="" apply="" the="" information="" in="" its="" files="" concerning="" common="" mechanism="" issues="" to="" most="" risk="" assessments,="" there="" are="" pesticides="" as="" to="" which="" the="" common="" mechanism="" issues="" can="" be="" resolved.="" these="" pesticides="" include="" pesticides="" that="" are="" toxicologically="" dissimilar="" to="" existing="" chemical="" substances="" (in="" which="" case="" the="" agency="" can="" conclude="" that="" it="" is="" unlikely="" that="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" activity="" with="" other="" substances)="" and="" pesticides="" that="" produce="" a="" common="" toxic="" metabolite="" (in="" which="" case="" common="" mechanism="" of="" activity="" will="" be="" assumed).="" epa="" does="" not="" have,="" at="" this="" time,="" available="" data="" to="" determine="" whether="" glyphosate="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances="" or="" how="" to="" include="" this="" pesticide="" in="" a="" cumulative="" risk="" assessment.="" unlike="" other="" pesticides="" for="" which="" epa="" has="" followed="" a="" cumulative="" risk="" approach="" based="" on="" a="" common="" mechanism="" of="" toxicity,="" glyphosate="" does="" not="" appear="" to="" produce="" a="" toxic="" metabolite="" produced="" by="" other="" substances.="" for="" the="" purposes="" of="" this="" tolerance="" action,="" therefore,="" epa="" has="" not="" assumed="" that="" glyphosate="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" c.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" since="" no="" toxicological="" endpoint="" of="" concern="" was="" identified,="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" acute="" exposures="" to="" glyphosate="" residues.="" 2.="" chronic="" risk.="" using="" the="" tmrc="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" glyphosate="" from="" food="" will="" utilize="" 1.2="" percent="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" non-="" nursing="" infants,="" which="" is="" further="" discussed="" below.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" exposure="" to="" glyphosate="" in="" drinking="" water="" and="" from="" non-="" dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" glyphosate="" residues.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" an="" ad="" hoc="" toxicology="" endpoint="" selection="" committee="" concluded="" that="" this="" risk="" assessment="" is="" not="" required,="" based="" on="" the="" lack="" of="" any="" observable="" effects="" in="" a="" 21-day="" dermal="" toxicity="" study="" at="" the="" limit="" dose="" and="" the="" observation="" of="" no="" adverse="" effects="" in="" a="" developmental="" toxicity="" study="" in="" rats="" up="" to="" 1,000="" mg/kg/day="" and="" rabbits="" up="" to=""> 175
mg/kg/day. Therefore, EPA concludes that there is a reasonable
certainty that no harm will result from aggregate short- and
inermediate-term exposure to glyphosate residues.
D. Aggregate Cancer Risk for U.S. Population
As noted above, glyphosate has been classified as a Group E
chemical (evidence of non-carcinogenicity for humans).
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children--a. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of glyphosate, EPA considered data from
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity
studies are designed to evaluate adverse effects on the developing
organism resulting from pesticide exposure during prenatal development
to one or both parents. Reproduction studies provide information
relating to effects from exposure to the pesticide on the reproductive
capability of mating animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a MOE analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. EPA believes that reliable data support using the standard MOE
and uncertainty factor (usually 100 for combined inter- and intra-
species variability)) and not the additional tenfold MOE/uncertainty
factor when EPA has a complete data base under existing guidelines and
when the severity of the effect in infants or children or the potency
or unusual toxic properties of a compound do not raise concerns
regarding the adequacy of the standard MOE/safety factor.
b. Developmental toxicity studies --i. Rat. In the rat
developmental toxicity study, the maternal (systemic) NOEL is 1,000 mg/
kg/day. The maternal (systemic) LOEL of 3,500 mg/kg/day was based on
the following treatment-related effects: diarrhea, decreased mean body
weight gain, breathing rattles, inactivity, red matter around the nose
and mouth, and on forelimbs and dorsal head, decreases in total
implantations/dam and non-viable fetuses/dam, and death (24% of the
group). The developmental (fetal) NOEL is 1,000 mg/kg/day. The
developmental (fetal) LOEL of 3,500 mg/kg/day was based on treatment-
related developmental effects observed only in the high-dose group of:
increased number of litters and fetuses with unossified sternebrae, and
decreased mean fetal body weights.
ii. Rabbit. In the rabbit developmental toxicity study, the
maternal (systemic) NOEL is 175 mg/kg/day. The maternal (systemic) LOEL
of 350 mg/kg/day was based on treatment-related effects that included:
diarrhea, nasal discharge, and death (62.5% of does died by gestation
day 21). The developmental (fetal) NOEL is 175 mg/kg/day
(insufficient litters were available at 350 mg/kg/day to assess
developmental toxicity). Developmental toxicity was not observed at any
dose tested.
c. Reproductive toxicity study--i. Rat. A three-generation
reproductive toxicity study was conducted with Sprague-Dawley rats, the
parental NOEL/LOEL is 30 mg/kg/day (highest dose tested).
The only effect observed was an increased incidence of focal tubular
dilation of the kidney (both unilateral and bilateral combined) in the
high-dose male F3b pups.
Since the focal tubular dilation of the kidneys was not observed at
the 1,500 mg/kg/day level (HDT) in the 2-generation rat reproduction
(see below),
[[Page 42926]]
but was observed at the 30 mg/kg/day level (HDT) in the 3-generation
rat reproduction study, the OPP Developmental Peer Review Committee
concluded that the latter was a spurious rather than glyphosate-related
effect. Therefore, the parental and reproductive (pup) NOELs are
30 mg/kg/day.
ii. Rat. A two-generation reproductive toxicity study was conducted
with Sprague-Dawley rats. Treatment-related effects observed in the
high dose group included: soft stools, very frequent, in the Fo and F1
males and females, decreased food consumption and body weight gain of
the Fo and F1 males and females during the growth (premating) period,
and decreased body weight gain of the F1a, F2a and F2b male and female
pups during the second and third weeks of lactation. Focal tubular
dilation of the kidneys, observed in the 3-generation study, was not
observed at any dose level in this study. Based on the above findings,
the parental and developmental (pup) NOEL's are 500 mg/kg/day and the
parental and developmental (pup) LOEL's are 1,500 mg/kg/day. The
reproductive toxicity NOEL is 1,500 mg/kg/day.
d. Pre- and post-natal sensitivity. Based on the developmental
toxicity studies discussed above, for glyphosate there does not appear
to be an extra sensitivity for pre-natal effects. The developmental rat
study only had developmental findings above 1,000 mg/kg/day in the
presence of severe maternal effects [death, etc.] at the highest dose
tested of 3,500 mg/kg/day. In rabbits, developmental effects above the
NOEL of 175 mg/kg/day were unable to be identified due to severe
maternal effects [death, etc.] at 350 mg/kg/day [highest dose tested].
Based on the reproductive toxicity study discussed above, for
glyphosate there does not appear to be an extra sensitivity for post-
natal effects. The pup and adult NOELs of 500 mg/kg/day and LOELs of
1,500 mg/kg/day do not demonstrate any post-natal extra sensitivity for
infants and children because the dose levels, respectively, are the
same for pups and adults and the effects are similar as well.
e. Conclusion. Therefore, the Agency concludes that no additional
10X safety factor is necessary to protect infants and children.
2. Acute risk. No endpoint was selected by the Agency so this risk
assessment was not conducted.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to
glyphosate from food will utilize no more than 3.3% of the RfD for non-
nursing infants, the most highly exposed sub-group. EPA generally has
no concern for exposures below 100% of the RfD because the RfD
represents the level at or below which daily aggregate dietary exposure
over a lifetime will not pose appreciable risks to human health.
Despite the potential for exposure to glyphosate in drinking water and
from non-dietary, non-occupational exposure, EPA does not expect the
aggregate exposure to exceed 100% of the RfD. EPA concludes that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to glyphosate residues.
V. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in plants and animals is adequately
understood. The current tolerances established under 40 CFR 180.364
include glyphosate and its metabolite aminomethylphosphonic acid
(AMPA). The Office of Pesticide Programs Metabolism Committee has
concluded that AMPA need not be regulated and should be dropped from
the tolerance regulation. The residue of concern is the parent
compound, glyphosate, only.
B. Analytical Enforcement Methodology
Adequate enforcement methodology (GLC and HPLC/fluorometric) are
available (PAM, Vol. II, Method I) to enforce the tolerance expression.
C. Magnitude of Residues
Residues of glyphosate, per se, are not expected to exceed the
following levels as a result of this Section 18 use. Time-limited
tolerances should be established at these levels: pea, dry at 5 ppm;
lentil at 5 ppm; pea, field vines at 60 ppm; pea, field hay at 200 ppm;
pea, field silage at 90 ppm; kidney, cattle, goats, horses, and sheep
at 4 ppm.
With the exception of the proposed increase in the kidney tolerance
noted above, secondary residues in animal commodities are not expected
to exceed existing tolerances as a result of this Section 18 use. The
dietary burden for livestock will not exceed that from the use on
grasses.
D. International Residue Limits
A CODEX MRL has been established for residues of glyphosate, per
se, on dry peas at 5 ppm. Canadian tolerances have been established for
residues of glyphosate and AMPA on peas at 5 ppm and lentils at 4 ppm.
E. Rotational Crop Restrictions
For this proposed Section 18 use, a 30-day plant-back interval for
crops on which glyphosate is not registered is being required.
VI. Conclusion
Therefore, the tolerance is established for residues of glyphosate
in dry peas, pea vines, hay, and silage, lentils, and kidney (cattle,
goats, horses and sheep) at 5, 60, 200, 90, 5, and 4, ppm,
respectively.
VII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by October 11, 1997, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request
[[Page 42927]]
may be claimed confidential by marking any part or all of that
information as Confidential Business Information (CBI). Information so
marked will not be disclosed except in accordance with procedures set
forth in 40 CFR part 2. A copy of the information that does not contain
CBI must be submitted for inclusion in the public record. Information
not marked confidential may be disclosed publicly by EPA without prior
notice.
VIII. Public Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300521] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7506C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes tolerances under FFDCA section
408(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408 (l)(5),
such as the tolerances in this final rule, do not require the issuance
of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency has
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance acations published on May
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
X. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the General Accounting Office prior to publication of this rule in
today's Federal Register. This is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Animal feeds, Food additives, Pesticides and
pests, Reporting and recordkeeping requirements.
Dated: July 29, 1997.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-- [AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. Section 180.364 is amended by adding text to paragraph (b) to
read as follows:
Sec. 180.364 Glyphosate; tolerances for residues.
(a) General . * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for combined residues of the herbicide glyphosate, per se
in connection with use of the pesticide under section 18 emergency
exemptions granted by EPA. The tolerances will expire and are revoked
on the dates specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Cattle, kidney.................. 4 August 30, 1998
Goats, kidney................... 4 August 30, 1998
Horses, kidney.................. 4 August 30, 1998
Lentils......................... 5 August 30, 1998
Pea, hay........................ 200 August 30, 1998
Pea, vines...................... 60 August 30, 1998
Peas, dry....................... 5 August 30, 1998
Sheep, kidney................... 4 August 30, 1998
Silage, hay..................... 90 August 30, 1998
------------------------------------------------------------------------
[[Page 42928]]
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[FR Doc. 97-21144 Filed 8-8-97; 8:45 am]
BILLING CODE 6560-50-F
